What does a clinical safety officer do?

What the standards require of the person

Both specifications set the same four requirements (section 2.3):

• A suitably qualified and experienced clinician.
• Holding a current registration with an appropriate professional body for their training and experience.
• Knowledgeable in risk management and its application to clinical domains.
• Making sure the processes defined by the clinical risk management process are followed.

DCB0129's glossary notes the role was previously called the "Responsible Person". Top management must nominate the CSO, and also define in the risk management plan who can authorise the system and its safety documents.

What the clinical safety officer signs

• The clinical risk management plan, including the risk acceptability criteria.
• Each version of the hazard log; an issued hazard log goes with every safety case report.
• Each clinical safety case report. A manufacturer produces one at each lifecycle phase in its plan; a deploying organisation produces one for deployment, use, maintenance and decommissioning.

A manufacturer and a hospital each need their own CSO. The supplier's CSO signs off the product's DCB0129 work; the hospital's CSO signs off the DCB0160 work for how the product is used locally.

Where the CSO appears elsewhere

In a DTAC assessment, section C1 (clinical safety) lists the clinical safety officer or engineer as the subject matter expert, with a chief clinical or nursing information officer, executive nurse or clinician as the accountable officer. The earlier DTAC form required the named CSO to have done NHS England's training; NHS England says that requirement no longer stands. NHS England Digital still runs digital clinical safety training for NHS organisations and manufacturers. Its guidance on AI ambient scribing puts "assign a clinical safety officer and identify key risks" as the first step.